Subtenon and Intravenous Dexmedetomidine Effect on Patients Undergoing Cataract Surgery

Acute Postoperative Pain Clinical Trial

Official title:

The Effect of Subtenon and Intravenous Dexmedetomidine on Patients Undergoing Cataract Surgery: A Comparative Randomized Controlled Double Blind Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04668456
• Other study ID #: 8/8/2020 ANET4
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: August 15, 2020
• Est. completion date: March 30, 2021

Study information

• Verified date: February 2021
• Source: Menoufia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study designed to compare the effects and the safety of adding dexmedetomidine to local anesthetics and its intravenous administration in subtenon block in patients undergoing cataract surgery.

Description:

Ophthalmological surgery can be performed under topical, regional or general anesthesia. Recently, the majority of ocular surgeries performed by regional rather than general anesthesia, because of the regional anesthesia is more economic, easy to perform, and the risk involved is less. Orbital regional anesthesia can be done using a retrobulbar (intra-conal) block, peribulbar (extra-conal) block or sub-Tenon's block.

The STBs or episcleral block was first described by Turnbull in 1884 and it was repopularized in the 1990s as a simple and safe alternative to needle-based eye blocks. The STB becomes the most widely practiced regional technique for cataract surgery, because it produces satisfactory anesthesia for most intraocular procedures, and avoids the inherent risks of needle-based blocks, such as globe perforation and optic nerve injury.

Dexmedetomidine is a selective α-2 receptor agonist that produces sedation and analgesia without causing respiratory depression. It also allows patients to respond to verbal commands during the sedation; easy conversion from sleeping to awakening is possible. Therefore, dexmedetomidine has been used as sedative in various clinical fields in intensive care unit and surgery and an adjuvant to local anesthetics.

Many studies were done to evaluate its effect as sedative or anlgesic when administered either intravenously or when added to local anesthesia in ophthalmic block. But no one, till now comparing its effect when used as adjuvant to local anesthetics or administered intravenously in subtenon block.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 75
• Est. completion date: March 30, 2021
• Est. primary completion date: March 14, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• ASA grade I-III

• Aged 18-70 years

• Both sex

• Scheduled for elective phacoemulsification cataract surgery

Exclusion Criteria:

• Coagulation abnormalities

• Impaired mental status

• Refusal of the patient

• Uncontrolled glaucoma

• Recent surgical procedure on the same eye

Related Conditions & MeSH terms

• Acute Postoperative Pain
• Cataract

Intervention

Drug:
• Dexmedetomidine
the drug administered either subtenon ot iv
• lidocaine 2%
subtenon injection
• bupivacine 0.5%
subtenon injection
• Normal saline
either subtenon or iv

Locations

Country	Name	City	State
Egypt	Ashraf magdy Eskandr	Shibin Al Kawm	Menoufiya
Egypt	Osama A Elmorsy	Shibin Al Kawm	Menoufiya
Egypt	Sadik A Sadik	Shibin Al Kawm	Menoufiya

Sponsors (1)

Lead Sponsor	Collaborator
Menoufia University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	duration of sensory block	time from injection of local anesthetic mixture to complete recovery from pain sensation or the first need of rescue analgesia	24 hours
Secondary	duration of motor block	time from injection of local anesthetic to complete recovery of motor function in all ocular muscles.	24 hours